fludarabine and cyclophosphamide with or without rituximab in patients with previously untreated chronic b-cell lymphocytic leukemia

Conditions: Leukemia

Summary: this randomized phase iii trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with b-cell chronic lymphocytic leukemia.


Eligibility criteria:
disease characteristics: * diagnosed b-cell chronic lymphocytic leukemia (cll) defined by the national cancer institute (nci) working group criteria * meets 1 of the following criteria: * binet stage c disease * binet stage b disease and ≥ 1 of the following signs or symptoms\*: * b symptoms (night sweats, weight loss ≥ 10% within the previous 6 months, fevers \> 38°c or 100.4°f for ≥ 2 weeks without evidence of infection), or constitutional symptoms (fatigue) * continuous progression (doubling of peripheral lymphocyte count within the past 6 months and absolute lymphocyte count \> 50 g/i) * evidence of progressive marrow failure as manifested by the development/worsening of anemia and/or thrombocytopenia * massive, progressive or painful splenomegaly or hypersplenism * massive lymph nodes or lymph node clusters (\> 10 cm in longest diameter), danger of organ complications through large lymphoma (e.g., vascular compression or tracheal narrowing), or progressive lymphadenopathy * occurrence of symptomatic hyperviscosity problems at leukocyte counts \> 200 g/i (symptomatic leukostasis) note: \* marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for eligibility * no binet stage a disease * no transformation to an aggressive b-cell malignancy (e.g., diffuse large cell lymphoma, richter's syndrome, or prolymphocytic leukemia) patient characteristics: * eastern cooperative oncology group (ecog) performance status 0-1 * cumulative illness rating scale (cirs) score \> 6 * life expectancy \> 6 months * bilirubin ≤ 2 times upper limit of normal (uln) * alkaline phosphatase and transaminases ≤ 2 times uln * creatinine clearance ≥ 70 ml/min * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 2 months after study treatment * no known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs * no cerebral dysfunction that precludes chemotherapy * no active bacterial, viral, or fungal infection * no clinically significant autoimmune cytopenia or coombs-positive hemolytic anemia * no other active malignancy requiring concurrent treatment except basal cell carcinoma or tumors treated curatively by surgery * no medical or psychological condition that would preclude study therapy * no concurrent disease that requires prolonged (\> 1 month) therapy involving glucocorticoids prior concurrent therapy: * no previous treatment of cll by chemotherapy, radiotherapy, or immunotherapy

Keywords: b-cell chronic lymphocytic leukemia stage i chronic lymphocytic leukemia stage ii chronic lymphocytic leukemia stage iii chronic lymphocytic leukemia stage iv chronic lymphocytic leukemia